1. Technical Field
This application relates to systems and methodologies for controlling prescription and dispensation of medication.
2. Description of Related Art
The effectiveness of a prescription medication to an individual patient is uncertain prior to its administration; therefore, prescribers rely on data showing the efficacy of a particular medication on the general population to evaluate if the medication may be beneficial to an individual patient. Once the medication is prescribed and treatment is received, the effectiveness of the medication in the patient is evaluated using gross clinical observation and the prescriber cannot always determine if the prescription is having the desired effect due to false positive drug response commonly known as the placebo effect. Additionally, most if not all prescription medications are associated with side effects having varying degrees of seriousness.
One class of drugs associated with serious adverse effects (“SAE's”), is so-called “Black Box” drugs. Some drugs, while efficacious in certain individuals, are known to carry with them the potential for serious adverse side effects. Because of this potential of serious adverse effects these drugs include a black outlined box prominently displayed on the drug's prescription label, intended to emphasize the greater risk inherent in such drugs, to help physicians avoid prescribing these drugs to patients who are taking other medications that could interact unfavorably with the Black Box drug, or who have risk factors that could elevate the risk of a known adverse event occurring, and to alert the patient of such potential adverse risks.
Compounding the problem of potential SAE's of such Black Box drugs, virtually all chronic care drugs, including Black Box chronic care drugs, do not work in substantial numbers of patients. In fact, non-response and placebo response rates can be as high as 70-80% with most drugs (including Black Box drugs) averaging around 50% for placebo response and non-response. This necessarily means that large numbers of patients are exposed to drugs having potentially SAE's but for which they do not receive a true effective benefit. For those drugs that do not have the potential to cause serious adverse effects, it is of lesser concern that such tolerable adverse effects might arise. Where the known adverse effect of a Black Box drug may be of such magnitude as to indicate it not be administered in the case where there is no demonstrated benefit, there is no justification to take the risk of such adverse effect.
Conventional methods use pre-screening questionnaires to determine if the patient may be at risk for side effects associated with a drug. One known approach provides methods for avoiding adverse side effects associated with a drug based on information probative of the risk of an adverse side effect, for example the age, weight and existing health conditions of the patient.
However, despite the use of such screening methods, the adverse effects of all drugs, including Black Box drugs, generally occur randomly throughout the population and therefore, because they occur randomly, there are no salient physical or demographic characteristics that would exclude a patient from being prescribed any particular drug. It thus is impossible for doctors to screen patients from receiving the Black Box drug before the patients are exposed to it for an extended period of time. Because of the potential for serious adverse effects, it is beneficial to the patient to assure, as quickly as possible, that he or she is receiving a true and not imagined benefit, sufficient to warrant the risk inherent in such drugs.
Furthermore, state and federal regulators do not have control over dispensation of a medication prescribed for “off-label” use—that is, for treatment of a condition not indicated by the label for that medication. It has been found that the administration of drugs for such off-label uses is commonly undertaken without sufficient scientifically derived evidence of efficacy, thereby exposing the patient to unknown risks and potentially reducing the efficacy of such drugs to the population as a whole through unwarranted overuse. For these reasons as well as to manage the risks associated with unanticipated SAE's that are not revealed during the drug development process, the Food and Drug Administration has now been given enhanced statutory oversight to manage drug safety with the passage of the Food and Drug Administration Amendments Act of 2007 and, as a result, can mandate drug safety programs in connection with the approval of prescription drugs. In this regard, the Food and Drug Administration (FDA) has proposed Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (September 2009) in which the FDA has offered the industry its guidance for such REMS including educational programs for patients and physicians or more restrictive programs that describe “safe use” conditions for certain very high risk drugs.
Therefore, a need exists for a method of evaluating the true clinical effectiveness of a black box prescription medication based on statistically valid evidence of effectiveness for its labeled indication(s) and then controlling the prescription and dispensation of the drug to only those who receive a benefit for its intended use in order to improve its risk/benefit ratio.